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NCT Number: NCT07021885

NLit and Outcomes in HNC Survivor-Caregiver Dyads

The goal of this observational (cross-sectional) study is to better understand nutrition literacy in survivor-caregiver dyads and its impact on nutrition related outcomes and quality of life. We're interested in finding out how much they know about nutrition and how this might relate to their overall health, body composition, functional status, and overall well-being. We will target post-treatment head and neck cancer survivors and a paired informal caregiver.

The main questions we aim to answer are:

* How does the nutrition literacy of both the survivor and caregiver relate to their sociodemographic, behavioral, and clinical characteristics? * How dyadic nutrition literacy influence individual nutrition outcomes like skin carotenoid levels, body composition, and functional status? * Does the shared nutrition knowledge (nutrition literacy) of both the survivor and caregiver impact their quality of life together?

Participants will:

Answer questions about their knowledge of nutrition. Have their nutritional health status checked. Use a non-invasive device to measure skin carotenoid content to validate self-reports of fruit and vegetable intake.

Have a simple and painless test to measure their body composition - like how much muscle and fat they have.

Do some physical tests like grip strength and walking to measure their physical ability.

Answer questions about their general well-being and lifestyle, like exercise and diet.

(For the survivor) Share details about their cancer, its treatment, and their overall well-being.

(For the caregiver) Answer questions about their role in taking care of the survivor, and their involvement in care routine such as food shopping and cooking.

Recruiting

Interested in participating?

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Key information

Conditions

Head and Neck Cancer Behavior Behavioral Symptoms Caregiver Burden Head and Neck Neoplasms Health Knowledge, Attitudes, Practice Neoplasms Neoplasms by Site Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Anna Arthur

CONTACT

[email protected]

913-945-7079

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Survivors and their caregivers will be eligible to participate if the survivor 1) has a history of oral cavity, pharyngeal, or laryngeal cancer, 2) is between 6 months - 4 years post-primary oncology treatment, 3) has no evidence of disease, 4) has an informal caregiver living in or out of the home who has a shared or primary role in food procurement and/or preparation, 5) no current use of feeding tube as the primary source of nutrition and can consume food orally, 6) age 18+, 7) English-speaking. Survivors and their caregivers will not be eligible to participate if either has 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia, 4) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ).

Exclusion criteria

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Treatment and study plan

Primary outcomes

  1. Nutrition Literacy

    Time frame: at a single time point between 6 months and 5 years post-treatment

    Measured by the self-administered Nutrition Literacy Assessment Instrument (NLit).

  2. Nutrition Status

    Time frame: at a single time point between 6 months and 5 years post-treatment

    Measured by the Mini Nutrition Assessment (MNA)

  3. Skin Carotenoid

    Time frame: at a single time point between 6 months and 5 years post-treatment

    Using the Veggie Meter®

  4. Body composition

    Time frame: at a single time point between 6 months and 5 years post-treatment

    Measured by BIA - InBody© 270, USA

  5. Functional status

    Time frame: at a single time point between 6 months and 5 years post-treatment

    Handgrip strength will be measured and recorded 3 times using the Jamar hand dynamometer on the dominant hand; Functional performance status will also be assessed using a short physical performance battery consisting of three functional tests assessing performance.

  6. Sociodemographics.

    Time frame: at a single time point between 6 months and 5 years post-treatment

    Age, biological sex, race, ethnicity, years of education, annual household income, employment status, pack-years smoking, alcohol consumption (current, former, never) will be self-reported.

  7. Fruit & Vegetable Intake

    Time frame: at a single time point between 6 months and 5 years post-treatment

    Using the Eating at America's Table Study's (EATS) All-Day screener designed, and validated by the National Cancer Institute

  8. Exercise

    Time frame: at a single time point between 6 months and 5 years post-treatment

    Assessed using a modified Godin Leisure-Time Exercise Questionnaire

  9. Food Security

    Time frame: At a single time point between 6 months and 5 years post-treatment

    Self-reported food security will be assessed using the USDA's U.S. Household Food Security Survey Module: Six-Item Short Form

  10. Caregiving characteristics

    Time frame: between 6 months and 5 years post-treatment

    Caregiver only: Caregivers will be asked to self-report their residence (in or out of survivor's home), years spent caregiving, hours per week spent caregiving, relationship to survivor, and role in food procurement and preparation

  11. Quality of life

    Time frame: between 6 months and 5 years post-treatment

    Caregiver: Overall quality of life will be assessed using the Caregiver FACT-General, which is structured and scored similarly to the FACT-HN but adapted for use in cancer caregivers. Cancer survivor: Overall quality of life will be assess using the Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) quality of life questionnaire.

  12. Clinical characteristics

    Time frame: between 6 months and 5 years post-treatment

    Tumor site, cancer stage, treatment modality, and HPV-status of the tumor will be collected through EMR review

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Nutrition Literacy and Associated Outcomes in Head and Neck Cancer Survivor-caregiver Dyads

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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